Use of Transcranial Magnetic Stimulation to Reduce Craving for Individuals With Opioid Use Disorder Taking Buprenorphine
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Cue-Induced Craving, as measured by 0-100 Visual Analog Scale
研究概览
简要总结
The aim of this study is to investigate the effects of transcranial magnetic stimulation (TMS) on craving in individuals treated with buprenorphine for opioid use disorder. In this study, individuals will receive 10 sessions of TMS (twice daily for 5 days). The investigators will assess craving, substance use, and mood throughout the study and 1-2 weeks post-treatment.
详细描述
The aim of this study is to investigate the effects of transcranial magnetic stimulation (TMS) on craving in individuals treated with buprenorphine for opioid use disorder. Investigators will enroll subjects aged 18-65 years old who are currently in treatment with buprenorphine for opioid use disorder. Included subjects will have initiated treatment with buprenorphine in the last 3 months, be able to read, write, and understand English, and, if female, agree to use contraception. Subjects will be excluded if they have a history of bipolar or psychotic illness, current depression, use substances other than opioids, take medications that lower seizure threshold or impair neuroplasticity, have chronic pain, have a history of seizure or any other uncontrolled medical issue, or have a device or ferromagnetic implant in the head or neck. Enrolled subjects will receive 10 (twice daily for 5 days) sessions of active TMS (intermittent theta burst stimulation) to the left dorsolateral prefrontal cortex (L DLPFC) on consecutive weekdays. Investigators will assess craving, substance use, and mood throughout the study and 1-2 weeks post-treatment completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years old
- •Initiated treatment with buprenorphine for opioid use disorder within the last 3 months
- •Be able to understand, read and write English.
- •If female and of childbearing age, agree to use acceptable birth control during the study treatment period (oral contraceptives, history of tubal ligation, history of a hysterectomy, or a reliable barrier method) during the study treatment period.
排除标准
- •Lifetime history of bipolar disorder or psychotic disorder,
- •Current depression as rated by PHQ-9 ≥ 20 (Kroenke, Spitzer, and Williams 2001, Suzuki et al. 2015)
- •Moderate chronic pain (pain intensity rated ≥ 40 on 100-point VAS lasting at least 6 months (Stein et al. 2015)
- •History of alcohol use disorder as rated by AUDIT-C ≥ 4 (at risk) (Babor et al. 2001)
- •History of complicated withdrawal from alcohol (i.e. delirium tremens, seizure)
- •Substance use disorder in the past year (other than opioid or nicotine), as assessed by drug screens,
- •Neurologic disease including stroke, seizure, migraine, or severe head injury
- •Major medical conditions that are not well-controlled or under the care of a physician
- •Device (i.e. pacemaker, cochlear prosthesis, neurostimulator, intraocular metallic fragments) or ferromagnetic implant above the neck (within 30 cm of coil),
- •Medication that lowers seizure threshold (i.e. immediate release bupropion, psychostimulants, tricyclic antidepressants) or impairs neuroplasticity (i.e. benzodiazepines)
结局指标
主要结局
Cue-Induced Craving, as measured by 0-100 Visual Analog Scale
时间窗: End of TMS Treatments (1 week)
Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving)
Drug Craving, as measured by 0-100 Visual Analog Scale
时间窗: End of TMS Treatments (1 week)
Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving)
次要结局
- Drug Craving, as measured by 0-100 Visual Analog Scale(1-2 weeks after completion of TMS treatments)
- Neuropsychologic Testing Battery(End of TMS treatment (1 week))
- Symptoms of Depression, as measured by the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)(1-2 weeks after completion of TMS treatments)
- Impulsivity(End of TMS treatment (1 week))
- Retention in Buprenorphine Treatment(1-2 weeks after completion of TMS treatments)
- Opioid Use and Relapse, as measured by Timeline Followback Calendar (days of opioid use)(1-2 weeks after completion of TMS treatments)
研究者
Heather Burrell Ward
Resident Physician in Psychiatry
Brigham and Women's Hospital